Total Clean Air : ISO 14644

The use of controlled Cleanrooms is necessary in areas such as food and drug production, as well as the manufacturing of certain products. Contaminants in Cleanrooms are tightly controlled to avoid negative effects on said products being made. Total Clean Air provides Cleanrooms that comply with the various standards set by the International Organization for Standardization. Our Cleanrooms comply with ISO 14644 standards on air cleanliness, which were established to address the need for uniform Cleanroom classification and testing.

ISO 14644 is divided into nine different sections, ranging from classification of air cleanliness in controlled environments to sorting out particle contamination stages.

  • ISO 14644-1 describes the classification of air cleanliness in classrooms and related environments. Air cleanliness is classified based on the concentration of airborne particulates present in the environment.
  • ISO 14644-2 identifies the necessary testing requirements needed to continuously meet ISO 14644-1 compliance. It also determines the factors needed for the maintenance of a Cleanroom or clean zone.
  • ISO 14644-3 identifies the testing methods used to classify airborne particulate cleanliness and for grouping the display rating of Cleanrooms and clean zones. Suppliers may use methods not included in ISO 14644-3, provided there is a valid agreement with the client.
  • ISO 14644-4 specifies the requirements needed for the design and construction of Cleanrooms and clean air facilities. It also mentions factors needed for start-up and qualification. Cleanroom designers and dealers must consider these factors to ensure ISO compliance. However, there are no recommended technological devices or steps to achieve the necessary requirements.
  • ISO 14644-5 outlines the requirements needed to run and maintain Cleanrooms and other controlled environments. It also highlights differences in the classification and operation of Cleanrooms against separative devices.
  • ISO 14644-6 is a vital guide for contamination control professionals, corroborating guidelines in ISO 14644 and other related ISO documents.
  • ISO 14644-7 provides the requirements needed for designing, constructing, installing and testing separative devices, such as isolators, mini-environments and clean air hoods.
  • ISO 14644-8 outlines the classification of airborne molecular contamination (AMC) in Cleanrooms. This takes into account airborne concentrations of specific chemical substances. Guidelines for testing, analysis and other necessary considerations are also included in the document.
  • ISO 14644-9 deviates from the airborne particles, describing particle contamination stages on solid surfaces in Cleanrooms and other controlled environments.
  • ISO 14644-10 deals with the classification of surface cleanliness, using chemical concentrations.
  • ISO 14644-12 classifies air cleanliness according to the concentration of nanoparticles in the controlled environment.

Our Cleanrooms at Total Clean Air are designed, manufactured, tested and maintained according to all applicable ISO standards. We are committed to providing quality Cleanroom solutions to our clients across all industries. Special attention is given to the testing and maintenance of our Cleanrooms and separative devices.

Modular Cleanroom Benefits

  • Modular Construction
  • Quick Assembly Time
  • Versatility
  • Reconfiguration
  • Airflow Control
  • Inexpensive Modifications

Testing

With ISO 14644-3, the testing methods are divided into two different types: unidirectional flow and nonunidirectional flow. Cleanrooms can be assessed in three states: immediately after construction, during periods of no activity, and when fully operational. Total Clean Air Cleanrooms are tested by ISO standards across the board. In addition, clients can specify other types of testing to be carried out on the facilities, depending on their preferences.

The testing standards provided in ISO 14644-3 are geared towards ensuring there is an internationally recognised and accepted framework for measuring and assessing airborne particulate cleanliness in Cleanrooms, while ISO 14644-9 classifies particulate contamination on clean surfaces. The ISO framework also takes into consideration the importance of innovation and makes provisions for new testing and Cleanroom technologies.

Testing also defines performance parameters, allowing for different testing methods to be applied, depending on the type of Cleanroom or clean zone. As expected, our Cleanrooms are regularly tested to ensure continued compliance with the classifications outlined in Part 1 of the ISO 14644 standards.

Cleanroom Design, Build & Validation

  • Budgeting and planning
  • Engineering, design & layout
  • Airflow and filtration design
  • Construction and Installation
  • Full Certification of our product
  • Industry-specific equipment installation
  • Validation

Criteria for Maintaining a Cleanroom

Cleanroom operators look to ISO 14644-5 for guidance to ensure products manufactured in Cleanrooms are of high quality and exceed customer expectations. This section of the ISO standards deals with protocols involved in the operation and maintenance of Cleanrooms to minimise contamination risks. These criteria are applicable to all Cleanrooms and controlled environments, regardless of type or function. There are six major annexes covered by the standards, including: operational systems, clothing, personnel, stationary equipment, mobile equipment and cleaning.

Operational Systems

Operational systems include the basic structures involved in the creation of products in Cleanrooms. In evaluating operating systems, managers must consider various factors, such as operational procedures, maintenance records, risk assessments, training, safety records, and modifications or upgrades. In Annex A of ISO 14644, information is provided with regards:

  • Safety programs
  • Subjects to be covered in training modules
  • Factors to be considered in modifying or upgrading a Cleanroom
  • Procedures for maintenance and monitoring of machines

Clothing

It’s important to consider that special clothing is required to prevent contamination by personnel handling products in Cleanrooms – and in some cases, protect the personnel from such products. In many Cleanrooms, staff moving in and out are the major potential sources of contamination. This makes the choice of clothing an essential aspect of Cleanroom function.

Three factors are considered when choosing clothing for Cleanroom personnel: safety, product sensitivity and the classification of Cleanroom. Annex B of ISO 14644 discusses the design and construction of garments for Cleanroom personnel, taking into consideration factors such as particulate control, temperature, electrostatic, as well as any storage issues.

Personnel

Annex C deals with training, protocols, rules and regulations pertaining to personnel working in all types and classes of Cleanrooms. Cleanroom operators can find policies relating to personnel in the guide to Cleanroom conduct. The annex also covers hygiene and safety protocols, including a sample gowning procedure.

Stationary Equipment

Annex D of ISO 14644 deals with stationary equipment in Cleanrooms. Equipment is another major source of contamination and must be carefully moved in and out of the Cleanroom. It’s important to consider the decontamination of equipment and method of transportation into the Cleanroom. It’s also essential to monitor installation procedures to minimise contamination risks.

For portable or mobile equipment, movement in and out of the Cleanroom must be monitored to minimise contamination. Maintenance and repair are also addressed in the annex. Emphasis is placed on maintenance before the equipment becomes contaminated and ensuring contamination controls are adhered to during the maintenance or repair process. Annex E provides information about cleaning tools, waste disposal, surface decontamination and site operational procedures.

Cleaning

In Annex F, operators can find standard cleaning methods, contamination tests, personnel training and cleaning schedules. The annex covers routine cleaning procedures, as well as cleanings during special situations such as construction and maintenance.

At Total Clean Air, our operational managers are well-equipped and experienced in maintaining Cleanroom standards, ensuring your products are manufactured in a safe and contamination-free environment.


Separative Devices

ISO 14644-4 and 14644-5 outline the differences between Cleanrooms and separative devices in terms of construction, installation, testing and maintenance. These devices include mini-environments, isolators, and clean air hoods. At Total Clean Air, we provide and manage separative devices with open or closed systems. Our devices are manufactured to the highest standards and fitted with proper air filters and filtration systems.

Since ISO 14644 does not specify certain requirements for separative devices; we make all decisions upon consultation with our clients, while devices are manufactured according to the clients’ specifications. This covers areas such as installation, operator requirements, protective clothing and safety regulations. Whilst building in accordance to the customers’ specifications, we strive for quality and excellence in all our separative devices.

Choose Total Clean Air as your expert in ISO-standard Cleanrooms

Our Cleanrooms are built according to standards outlined in the ISO 14644 documents. We pride ourselves on maintaining those standards, whilst ensuring optimal customer satisfaction. Whatever your industry, we will provide the Cleanrooms you require to run your business. From laboratories to manufacturing plants, we can design and build according to your specifications, ensuring you can create high-quality products in a secure and decontaminated environment. We also provide testing and validation of Cleanrooms to ensure they are in compliance with ISO 14644 standards.

At Total Clean Air, we provide Cleanroom HVAC and other air handling requirements necessary to keep the environment clean. Electrical installations and furnishings are also conducted to the highest standards to limit the risk of contamination. If you have a Cleanroom you need testing, contact us now and our experts will ensure your Cleanrooms are fully functional by completing checks such as particle counting, filter testing, pressure testing and lighting levels.

We also ensure your Cleanroom is designated the proper classification for its purpose, based on particulate concentration. Maintenance and cleaning are performed on a regular basis to ensure all systems continue to function at optimum levels. Containment units are deployed during maintenance and repair to avoid disrupting the controlled environment.

Don’t hesitate to contact us today for your Cleanroom design, installation, and maintenance. Our certified engineers are always available to provide one-on-one consultations and site visitations to determine your specific needs.

phillip.godden
Phillip Godden

Phillip Godden is the Founder & Chief/Executive Officer at Total Clean Air.

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